Application 215069

Type: ANDA
Sponsor: SCIEGEN PHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LEVETIRACETAM	LEVETIRACETAM	TABLET;ORAL	750MG	No	No
002	LEVETIRACETAM	LEVETIRACETAM	TABLET;ORAL	1GM	No	No
003	LEVETIRACETAM	LEVETIRACETAM	TABLET;ORAL	250MG	No	No
004	LEVETIRACETAM	LEVETIRACETAM	TABLET;ORAL	500MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A215069-001	LEVETIRACETAM	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2021-06-11
A215069-002	LEVETIRACETAM	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2021-06-11
A215069-003	LEVETIRACETAM	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2022-05-27
A215069-004	LEVETIRACETAM	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2022-05-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A215069-001	AB
A215069-002	AB
A215069-003	AB
A215069-004	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 4 · 124 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A215069-001	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2021-06-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215069-002	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2021-06-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215069-003	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2022-05-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215069-004	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2022-05-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215069-001	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2021-06-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215069-002	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2021-06-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215069-003	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2022-05-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215069-004	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2022-05-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215069-001	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2021-06-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215069-002	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2021-06-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215069-003	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2022-05-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215069-004	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2022-05-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215069-001	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2021-06-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215069-002	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2021-06-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215069-003	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2022-05-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215069-004	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2022-05-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215069-001	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2021-06-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215069-002	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2021-06-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215069-003	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2022-05-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215069-004	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2022-05-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215069-001	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2021-06-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215069-002	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2021-06-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215069-003	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2022-05-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215069-004	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2022-05-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215069-001	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2021-06-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215069-002	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2021-06-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215069-003	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2022-05-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215069-004	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2022-05-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215069-001	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2021-06-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215069-002	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2021-06-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215069-003	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2022-05-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215069-004	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2022-05-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215069-001	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2021-06-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215069-002	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2021-06-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215069-003	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2022-05-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215069-004	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2022-05-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215069-001	LEVETIRACETAM	750MG	TABLET / ORAL	AB	2021-06-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215069-002	LEVETIRACETAM	1GM	TABLET / ORAL	AB	2021-06-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215069-003	LEVETIRACETAM	250MG	TABLET / ORAL	AB	2022-05-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215069-004	LEVETIRACETAM	500MG	TABLET / ORAL	AB	2022-05-27	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 122 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A215069-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215069-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215069-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215069-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215069-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215069-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215069-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215069-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215069-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215069-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215069-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215069-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215069-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215069-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215069-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215069-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215069-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215069-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215069-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215069-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215069-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215069-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215069-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215069-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215069-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215069-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215069-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215069-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215069-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215069-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215069-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215069-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215069-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215069-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215069-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215069-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215069-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215069-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215069-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215069-004	AB	1	`d06236e962d9…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Levetiracetam	LEVETIRACETAM	A-S Medication Solutions	c3daf220-9741-41c4-b89d-e06cee36dac6	2025-12-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215069 application number: ANDA215069
Levetiracetam	LEVETIRACETAM	Coupler LLC	43df4156-0958-e496-e063-6294a90a5329	2025-11-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215069 application number: ANDA215069
Levetiracetam	LEVETIRACETAM	A-S Medication Solutions	8a8472dc-b97e-445d-bf51-b6e618cae1b6	2024-10-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215069 application number: ANDA215069
Levetiracetam	LEVETIRACETAM	ScieGen Pharmaceuticals, Inc.	1d71212b-ac97-4a61-8192-8e8303540019	2024-08-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215069 application number: ANDA215069 ndc (product): 50228-471 ndc (product): 50228-473 ndc (product): 50228-470 ndc (product): 50228-472

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50228-470	Levetiracetam	Levetiracetam	ScieGen Pharmaceuticals, Inc.	ANDA	Current
50228-470	Levetiracetam	Levetiracetam	ScieGen Pharmaceuticals, Inc.	ANDA	Current
50228-471	Levetiracetam	Levetiracetam	ScieGen Pharmaceuticals, Inc.	ANDA	Current
50228-471	Levetiracetam	Levetiracetam	ScieGen Pharmaceuticals, Inc.	ANDA	Current
50228-472	Levetiracetam	Levetiracetam	ScieGen Pharmaceuticals, Inc.	ANDA	Current
50228-472	Levetiracetam	Levetiracetam	ScieGen Pharmaceuticals, Inc.	ANDA	Current
50228-472	Levetiracetam	Levetiracetam	ScieGen Pharmaceuticals, Inc.	ANDA	Current
50228-473	Levetiracetam	Levetiracetam	ScieGen Pharmaceuticals, Inc.	ANDA	Current
50228-473	Levetiracetam	Levetiracetam	ScieGen Pharmaceuticals, Inc.	ANDA	Current
50228-473	Levetiracetam	Levetiracetam	ScieGen Pharmaceuticals, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
68085	ORIG	2021-07-14
68084	ORIG	2021-07-14